Whether it is your first time or your tenth time, handling medical device labeling can be a cumbersome process. With constant regulatory changes, new challenges always face your team and sometimes you may feel lost.
Join Morningside on October 27 from 1pm-2pm EST, as we partner with Network Partners to speak about the challenges regulatory teams face in medical device labeling. Experts, Heather Valley and Anna Eisenberg, will provide critical information you will need to better understand labeling and prepare for submission.
From prioritizing the process, understanding basic requirements, and planning for translations, this one-hour-long webinar will cover the an extensive range of topics you will need to feel prepared for the next steps in your labeling process.
Prioritize your Process
The labeling process has many moving pieces. Not prioritizing it is often how organizations face risking the loss of money, time, and in worse cases, reputation. Planning early and speaking about your process will allow for ownership, accountability, planning/execution, and the elimination of silos.
With multiple departments and individuals involved in labeling, ownership and accountability are paramount in ensuring each step is completed properly along the way. We will discuss what a “good” labeling process looks like and dive into all the benefits you can gain from implementing practical and effective steps in your company.
Basics of Regulatory Requirements
Join us as our experts go over the basics of regulatory requirements that you need to know:
- Unique Device Identifiers
Gain an understanding of what types of product literature fall under labeling. Learn about how symbology is used, such as standards, symbols, and even size and color. Take a look with us as we dive into what Unique Device Identifiers are, what goes into them, and how they are read. Then finally, we’ll explore e-labels and the challenges you can expect to face when using them.
Plan for Translations
Learn about the lasting benefits of working with an experienced life science language services provider (LSP). We’ll discuss how partnering with one LSP for all of your complex multi-language projects helps increase security, organizes workflow, saves time in compliance, and reduces costs.
Discover the advantages of working with a LSP that specializes in regulatory submissions, packaging, labels, IFUs, manuals, and software. As well as one that has experience working with regulatory bodies around the globe and the tools needed to let you meet compliance.
Medical Device Labeling Industry Expertise
We will have two expert speakers from the regulatory and translation industries: Heather Valley, Senior Director of Regulatory Affairs at Network Partners, and our very own Anna Eisenberg, Associate Director of Life Science Business Development at Morningside, a Questel Company.
Heather Valley is a Senior Director of Regulatory Affairs at Network Partners, a professional services firm that helps clients complete the work necessary to provide their products to patients. Serving the medical device, pharmaceutical and biopharmaceutical industries with core competencies in Regulatory Affairs, CER, Packaging Engineering, Labeling, Quality and Project Management.
Heather is passionate about “working smarter, not harder”. She knows the challenges in the life science industry; with the constant changes, understands key issues, and their implications and takes the following steps to get clients on the path to compliance while getting their products to the patients that need them most.
Anna Eisenberg is an Associate Director of Life Science Business Development at Morningside, with 20+ years of experience in the localization industry and a focus on life sciences. She is responsible for the company’s life science strategy and maintaining relationships with global leaders in the field. Anna expertly advises pharmaceutical and medical device companies on best translation practices and is an expert in implementing workflows that improve quality, reduce costs, and accelerate deadlines.
Morningside, a Questel Company equips the world’s leading life sciences organizations with a full suite of end-to-end language solutions for their regulatory, clinical, commercial and patent needs. With over 4,000 clients in 55 countries, we’re globally recognized for our life science expertise and technology innovation across pharma, biotech, medical devices, and healthcare. Our life sciences translation services ensure your products and ideas seamlessly reach new markets and comply with all regulatory and cultural requirements through every stage of the product lifecycle — from patent to post-market.
We hope you can join us for our webinar “Challenges and Changes in Regulatory Medical Device Labeling” on October 27th from 1PM-2PM est. If you cannot make that time, please feel free to register anyways, we will be sharing the recorded webinar with all registrants post-event. Not only will this webinar help you save time, but you will help ensure compliance in your organization and build your reputation. You won’t want to miss out on this critical presentation for the medical device industry. Register today for free attendance!